Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:47 AM
Study NCT ID:
NCT07447193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Pain Perception According to Gender in Individuals With Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scoliosis Research Society-22', 'timeFrame': '8 weeks', 'description': 'Scoliosis Research Society-22 is a functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.'}, {'measure': 'Walter Reed Visual Assessment Scale', 'timeFrame': '8 weeks', 'description': 'Walter Reed Visual Assessment Scale (WRGDS) is an evaluation scale created from visual figures. It was developed by Pineda et al. in 2006, for use in individuals with scoliosis, to measure how a person thinks about the deformity in their own body and how severe it is perceived.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis']}, 'referencesModule': {'references': [{'pmid': '40009184', 'type': 'BACKGROUND', 'citation': 'Khodaei M, Parent EC, Wong J, Chan A, Coutts B, Dlikan M, Fehr B, Logithasan V, Sayed T, Mendoza A, Ganzert C, Lou EHM. Identifying predictors of brace treatment outcomes for adolescents or adults with idiopathic scoliosis: a systematic review. Eur Spine J. 2025 May;34(5):1827-1848. doi: 10.1007/s00586-025-08736-w. Epub 2025 Feb 26.'}, {'pmid': '40343930', 'type': 'BACKGROUND', 'citation': 'Bourtzoni S, Reed P. Pain perception in personality disorders. PLoS One. 2025 May 9;20(5):e0323004. doi: 10.1371/journal.pone.0323004. eCollection 2025.'}, {'pmid': '27625122', 'type': 'BACKGROUND', 'citation': 'Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis.', 'detailedDescription': 'This study will be conducted using a single-group pre-test-post-test quasi-experimental design. Participants will undergo sports physiotherapy-based exercises designed to create controlled mechanical pressure on the spine using a physiotherapy roller. The aim of the exercises is to evaluate the changes in pain perception during the pressure created on the spinal infrastructure and the postural control mechanisms specific to scoliosis, and whether these changes differ according to gender. The exercise program will be applied three days a week for a total of six weeks, with each exercise session lasting approximately 45 minutes. All applications will be performed under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy roller during the exercises will be controlled and within the limits that individuals can tolerate. The physiotherapy roller will be used as the main equipment in this study, not as an auxiliary tool, and will ensure that spinal pressure is created in a standard manner. Pain assessment will be conducted in two stages: before the exercise program (pre-test) and after the exercise program is completed (post-test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a clinical or radiological diagnosis of scoliosis\n* Being between 18-45 years of age\n* Not having undergone scoliosis surgery in the last 6 months\n* Agreeing to participate in the study voluntarily\n\nExclusion Criteria:\n\n* Having a history of neurological disease\n* Acute inflammatory spinal disease\n* Serious cardiovascular or systemic diseases that would prevent participation in exercise'}, 'identificationModule': {'nctId': 'NCT07447193', 'briefTitle': 'Investigation of Pain Perception According to Gender in Individuals With Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Investigation of Pain Perception According to Gender in Individuals With Scoliosis', 'orgStudyIdInfo': {'id': 'Uskudar90'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': 'exercise will be given', 'interventionNames': ['Other: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'OTHER', 'description': 'The exercise program will be implemented three days a week for a total of six weeks, with each exercise session planned to be approximately 45 minutes long. All applications will be carried out under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy cylinder during the exercises will be controlled and applied within the limits that individuals can tolerate. The physiotherapy cylinder will be used as the main equipment, not an auxiliary one, in this study and will ensure that spinal pressure is created in a standard manner.', 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ömer ŞEVGİN', 'role': 'CONTACT', 'email': 'omer.sevgin@uskudar.edu.tr', 'phone': '+905069787535'}], 'overallOfficials': [{'name': 'Aynur SHIRALIZADA', 'role': 'STUDY_CHAIR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.Dr.', 'investigatorFullName': 'Doç.Dr.Ömer Şevgin', 'investigatorAffiliation': 'Uskudar University'}}}}